A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
This randomized, open-label, multi-center study will evaluate the sustained virological
response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with
Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection.
Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will
be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to
Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir
100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg
twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive
Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day
for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180
microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.
In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus
treatment.